RegeneRx Biopharmaceuticals, Inc. announced that the first patient has been enrolled in its phase 3 clinical trial assessing RGN-259, its novel drug candidate, for the treatment of neurotrophic keratitis (NK).
Give me some background on the company.
RegeneRx Biopharmaceuticals is a biopharmaceutical company seeking to develop Thymosin beta 4 (Tß4), a novel therapeutic peptide, for the protection, repair, and regeneration of tissue and organs.
The companies clinical pipeline includes three product candidates of Tß4:
RGN-259 (topical eye drop)
RGN-137 (topical gel)
RGN-352 (injectable formulation)
Now talk about RGN-259.
RegeneRx’s Tß4-based sterile and preservative-free eye drop is designed to potentially treat both dry eye disease (DED) and NK.
The novel drug candidate promotes cell migration and wound healing; it’s also the first pharmaceutical agent of its kind that has demonstrated corneal repair and anti-inflammatory properties.
To note, the FDA granted RGN-259 Orphan Drug status for NK treatment in 2013.
Give me some background on its development.
RGN-259 is being developed by a US joint venture between RegeneRx and HLB Therapeutics called ReGenTree, LLC.
How has it performed in previous trials?
The first phase 3 trial (SEER-1) (NCT02600429) found that 60% of RGN-259-treated patients achieved complete corneal healing. The primary endpoint—ratio of corneal wound healed after 4 weeks’ administration—reported highly significant or strongly trending toward statistical significance within the RGN-259 group.
Talk about this phase 3 trial.
The SEER-2 trial (NCT05555589) is a double-masked, placebo-controlled trial that is enrolling an estimated 70 patients diagnosed with NK.
Participants will be administered either a 0.1% RGN-259 ophthalmic solution or placebo eye drops five times a day for 4 weeks; the primary endpoint is “complete corneal healing,” as determined by corneal fluorescein staining (CFS).
Anything else to know?
The SEER-2 trial is being conducted simultaneously with the phase 3 SEER-3 trial, including the exact same trial set up, patient enrollment, and primary endpoint. Taking into consideration that NK is a rare disease, ReGenTree plans on recruiting from 30+ clinical institutions across the United States.
Why simultaneous?
By conducting the two trials at once, ReGenTree is looking to significantly shorten the clinical development time period for RGN-259.
What’s next?
According to ClinicalTrials.gov, the SEER-2 study is expected to be completed by February 2024. Stay tuned for more updates!